Eur Respir J 2006; 28: 687–690
DOI: 10.1183/09031936.06.00097506
CopyrightßERS Journals Ltd 2006
EDITORIAL
Improving the TB case management: the International
Standards for Tuberculosis care
G.B. Migliori*, P.C. Hopewell#, F. Blasi", A. Spanevello+ and M.C. Raviglione1
uberculosis (TB) is currently the leading cause of death
T from a curable infectious disease [1]. The World Health
Organization (WHO) estimates that 8.9 million new TB
cases occurred in 2004 (of which 3.9 million were sputum
smear positive), although only about half of the estimated
number were reported by public health systems [1, 2].
Whilst the highest TB incidence rate is in sub-Saharan Africa
(estimated to be 356 new cases per 100,000 population per yr),
in most countries of the former Soviet Union the estimated
incidence rate exceeds 100 new cases per 100,000 population
per yr [1, 2].
Although the rate of increase in the TB incidence rate is
decreasing, the global TB notification grew by 1% between
2003 and 2004, the last year for which data are available. This
continued increase is largely the result of the striking increase
in cases in sub-Saharan Africa and, to a lesser extent, in the
former USSR. Whilst the worsening of the TB incidence in Africa
is due to the HIV epidemic compounded by an insufficient health
infrastructure, it is due to different causes in Eastern Europe,
including economic decline, increased poverty, social disruption
and sub-standard health services. In addition, as a result of these
factors, .10% of new TB cases in the Baltic states and in some
parts of Russia are multidrug-resistant (MDR-TB), i.e. resistant to
at least isoniazid and rifampicin [3].
In the European region, 445,000 new TB cases and nearly 70,000
deaths were estimated to have resulted from TB in 2004. In the
Eastern part of the region, the levels of directly observed treat-
ment, short-course (DOTS) strategy coverage and case detection
are the lowest among the world regions, and the overall
treatment success rate is the second lowest (75%) after Africa [2].
THE NEW STOP TB STRATEGY FOR TB CONTROL
The DOTS strategy (composed of five key elements: govern-
ment commitment, bacteriological diagnosis, standardised and
supervised treatment, uninterrupted drug supply, and regular
programme monitoring) has greatly contributed to improved
*WHO Collaborating Center for Tuberculosis and Lung Diseases, Fondazione S. Maugeri, Care and
Research Institute, Tradate, "Istituto Malattie Respiratorie, Università degli Studi di Milano,
Padiglione Sacco, Ospedale Maggiore Milano, IRCCS Fondazione Policlinico-Mangiagalli-Regina
Elena, Milan, and +University of Foggia, Fondazione S. Maugeri, Cassano Delle Murge, Bari, Italy.
#
Francis J Curry National Tuberculosis Center, University of California, San Francisco, CA, USA.
1
Stop TB Dept, World Health Organization, Geneva, Switzerland.
CORRESPONDENCE: G.B. Migliori, WHO Collaborating Centre for Control of Tuberculosis and Lung
Diseases in Europe, Fondazione Salvatore Maugeri, Care and Research Institute, via Roncaccio 16,
21049 Tradate, Italy. Fax: 39 0331829402. E-mail: gbmigliori@fsm.it
EUROPEAN RESPIRATORY JOURNAL
global TB control during the past decade [4, 5]. As of the end of
2004, 183 countries had adopted DOTS, and the latest
performance assessments show that the global case detection
rate was 53% (cases notified/estimated number of cases) in
2004, and the percentage of patients treated successfully was
82% in the 2003 cohort.
Several examples of country success stories have been
reported, including China (significant reduction in the pre-
valence of pulmonary, smear-positive and culture-positive TB)
[6], Peru (incidence of TB declining 6% per annum after DOTS
introduction) [7], India (600,000 additional lives saved during
the first 8 yrs of DOTS implementation), Cuba, Tanzania and
Malawi among others [4].
However, for a variety of reasons, DOTS has not been
sufficient to control the epidemic in sub-Saharan Africa or
Eastern Europe. To address these and other challenges to TB
care and control, the WHO developed a broader approach that
is embodied in the new Stop TB Strategy. The new strategy,
while keeping DOTS as the first and foremost of its six
components [5], has made explicit five additional components
that must be implemented to reach the 2015 Millennium
Development Goals relevant to TB. These have the following
aims: 1) to pursue high-quality DOTS expansion and enhance-
ment; 2) to address TB/HIV, MDR-TB and other challenges; 3)
to contribute to health system strengthening; 4) to engage all
care providers; 5) to empower people with TB, and commu-
nities; and 6) to enable and promote research.
Within these six components, the engagement of all care
providers is of utmost importance and deserves emphasis.
Many patients with symptoms caused by what ultimately is
proven to be TB initially seek care in the private sector and
many private providers both diagnose and treat the disease.
Relying solely on governmental services in many areas greatly
limits TB control efforts. Since prompt, accurate diagnosis and
effective treatment to cure are the core elements of TB control,
it is essential that all practitioners who provide TB services do
so in an effective manner in conformance with international
standards.
THE INTERNATIONAL STANDARDS FOR TUBERCULOSIS
CARE
The International Standards for Tuberculosis Care (ISTC) docu-
ment [8] has been developed as a tool that can be used to unify
public and private sectors in providing high-quality care for
TB. The ISTC is intended to facilitate the effective delivery of
high-quality care for all patients regardless of age or sex, c
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INTERNATIONAL STANDARDS FOR TB CARE G.B. MIGLIORI ET AL.

TABLE 1 The International Standards for Tuberculosis Care

Standards

Standards for diagnosis

Standard 1 All persons with otherwise unexplained productive cough lasting o2–3 weeks should be evaluated for TB
Standard 2 All patients (adults, adolescents and children who are capable of producing sputum) suspected of having pulmonary
TB should have at least two, and preferably three, sputum specimens obtained for microscopic examination.
When possible, at least one early morning specimen should be obtained
Standard 3 For all patients (adults, adolescents and children) suspected of having extrapulmonary TB, appropriate specimens
from the suspected sites of involvement should be obtained for microscopy and, where facilities and resources are
available, for culture and histopathological examination
Standard 4 All persons with chest radiographic findings suggestive of TB should have sputum specimens submitted for
microbiological examination
Standard 5 The diagnosis of sputum smear-negative pulmonary TB should be based on the following criteria: at least three
negative sputum smears (including at least one early morning specimen); chest radiography findings consistent
with TB; and lack of response to a trial of broad-spectrum antimicrobial agents. (Since fluoroquinolones are active
against M. tuberculosis complex, and thus may cause transient improvement in persons with TB, they should be
avoided). For such patients, if facilities are available, sputum cultures should be obtained. In persons with known
or suspected HIV infection, the diagnostic evaluation should be expedited
Standard 6 The diagnosis of intrathoracic (i.e. pulmonary, pleural, and mediastinal or hilar lymph node) TB in symptomatic
children with negative sputum smears should be based on the finding of chest radiographic abnormalities
consistent with TB and either a history of exposure to an infectious case or evidence of TB infection (positive tuberculin
skin test or interferon gamma release assay). For such patients, if facilities for culture are available, sputum
specimens should be obtained (by expectoration, gastric washings, or induced sputum) for culture
Standards for treatment
Standard 7 Any practitioner treating a patient for TB is assuming an important public health responsibility. To fulfil this
responsibility, the practitioner must not only prescribe an appropriate regimen, but also be capable of assessing
the adherence of the patient to the regimen and addressing poor adherence when it occurs. By so doing, the
provider will be able to ensure adherence to the regimen until treatment is completed
Standard 8 All patients (including those with HIV infection) who have not been treated previously should receive an internationally
accepted first-line treatment regimen using drugs of known bioavailability. The initial phase should consist of 2
months of isoniazid, rifampicin, pyrazinamide and ethambutol. The preferred continuation phase consists of
isoniazid and rifampicin given for 4 months. Isoniazid and ethambutol given for 6 months is an alternative
continuation-phase regimen that may be used when adherence cannot be assessed, but it is associated with a
higher rate of failure and relapse, especially in patients with HIV infection. The doses of anti-TB drugs used should
conform to international recommendations. Fixed-dose combinations of two (isoniazid and rifampicin), three
(isoniazid, rifampicin (or rifampin) and pyrazinamide), and four (isoniazid, rifampicin, pyrazinamide and
ethambutol) drugs are highly recommended, especially when medication ingestion is not observed
Standard 9 To foster and assess adherence, a patient-centred approach to administration of drug treatment, based on the
patient’s needs and mutual respect between the patient and the provider, should be developed for all patients.
Supervision and support should be sex sensitive and age specific and should draw on the full range of
recommended interventions and available support services, including patient counselling and education. A central
element of the patient-centred strategy is the use of measures to assess and promote adherence to the treatment
regimen and to address poor adherence when it occurs. These measures should be tailored to the individual
patient’s circumstances and be mutually acceptable to the patient and the provider. Such measures may include
direct observation of medication ingestion (DOT) by a treatment supporter who is acceptable and accountable to
the patient and to the health system
Standard 10 All patients should be monitored for response to therapy, best judged in patients with pulmonary TB by follow-up
sputum microscopy (two specimens) at least at the time of completion of the initial phase of treatment (2 months),
at 5 months and at the end of treatment. Patients who have positive smears during the 5th month of treatment
should be considered as treatment failures and have therapy modified appropriately (see standards 14 and 15). In
patients with extrapulmonary TB and in children, the response to treatment is best assessed clinically. Follow-up
radiographic examinations are usually unnecessary and may be misleading
Standard 11 A written record of all medications given, bacteriological response and adverse reactions should be maintained for
all patients
Standard 12 In areas with a high prevalence of HIV infection in the general population and where TB and HIV infection are likely to
co-exist, HIV counselling and testing are indicated for all TB patients as part of their routine management. In areas
with lower prevalence rates of HIV, HIV counselling and testing are indicated for TB patients with symptoms and/or
signs of HIV-related conditions and in TB patients having a history suggestive of high risk of HIV exposure

688 VOLUME 28 NUMBER 4 EUROPEAN RESPIRATORY JOURNAL

G.B. MIGLIORI ET AL. INTERNATIONAL STANDARDS FOR TB CARE

TABLE 1 Continued
Standards

Standard 13 All patients with TB and HIV infection should be evaluated to determine if antiretroviral therapy is indicated during
the course of treatment for TB. Appropriate arrangements for access to antiretroviral drugs should be made for
patients who meet indications for treatment. Given the complexity of co-administration of anti-TB treatment and
antiretroviral therapy, consultation with a physician who is expert in this area is recommended before initiation of
concurrent treatment for tuberculosis and HIV infection, regardless of which disease appeared first. However,
initiation of treatment for TB should not be delayed. Patients with TB and HIV infection should also receive
cotrimoxazole as prophylaxis for other infections
Standard 14 An assessment of the likelihood of drug resistance, based on history of prior treatment, exposure to a possible
source case having drug-resistant organisms, and the community prevalence of drug resistance should be
obtained for all patients. Patients who fail treatment and chronic cases should always be assessed for possible
drug resistance. For patients in whom drug resistance is considered to be likely, culture and drug susceptibility
testing for isoniazid, rifampicin and ethambutol should be performed promptly
Standard 15 Patients with TB caused by drug-resistant (especially MDR) organisms should be treated with specialised regimens
containing second-line anti-TB drugs. At least four drugs to which the organisms are known or presumed to be
susceptible should be used, and treatment should be given for o18 months. Patient-centred measures are
required to ensure adherence. Consultation with a provider experienced in treatment of patients with MDR-TB
should be obtained
Standards for public health responsibilities
Standard 16 All providers of care for patients with TB should ensure that persons (especially children aged ,5 yrs and persons
with HIV infection) who are in close contact with patients who have infectious TB are evaluated and managed in
line with international recommendations. Children aged ,5 yrs and persons with HIV infection who have been in
contact with an infectious case should be evaluated for both latent infection with M. tuberculosis and for active TB
Standard 17 All providers must report both new and retreatment TB cases and their treatment outcomes to local public health
authorities, in conformance with applicable legal requirements and policies

TB: tuberculosis; DOT: directly observed therapy; MDR: multidrug resistant.

including the ‘‘complicated’’ cases, i.e. those who are sputum
smear negative, have extrapulmonary sites of disease, and
those who are affected by MDR-TB or co-infected with HIV.
They are designed to put the patient at the centre of care and
the healthcare provider at the centre of TB control. As
summarised in table 1, the document includes six standards
for diagnosis, nine standards for treatment and two standards
addressing public health responsibilities.
As accurate diagnosis and effective treatment are the core of
both TB care and TB control, any clinician providing TB
services to individual patients is, by definition, assuming an
important public health function as well as providing
individual patient care. Thus, at the centre of the ISTC is the
notion of both individual and public health responsibility. The
ISTC emphasises that TB diagnosis should be promptly and
adequately established, based, whenever possible, on bacterio-
logical evidence. Internationally recommended treatment regi-
mens of proven quality should be prescribed, using the
recommended doses, and for the recommended duration, with
appropriate treatment support and supervision. The response
to treatment should be monitored and microbiological exam-
inations performed after the initial intensive phase of
treatment, after 5 months and at the end of treatment. The
essential public health responsibilities are to be fully satisfied,
including evaluation and management of close contacts, as
well as case notification and reporting of new cases and
treatment outcomes.
EUROPEAN RESPIRATORY JOURNAL
The ISTC, in underlining the importance of these essential care
operations, is fully consistent with WHO recommendations, as
described in a number of guidelines published over the years,
and complementary to local and national TB control policies.
The ISTC document is also consistent with European
Respiratory Society guidelines [9, 10].
Although the ISTC is evidence based and widely accepted, it is
only a tool, not an end in itself. To achieve adherence to the
ISTC, it is critical that it has sufficient ‘‘weight’’ to wield
influence and that it is disseminated to relevant practitioners.
This can best be achieved by having the broad endorsement of
influential medical and nursing professional societies, both
national and international, and that these societies develop
educational activities based on the ISTC. Of key importance is
the close collaboration with the national TB programme and
the synergistic attempt to include the ISTC among the basic
tools required for the proper implementation of public–private
mix DOTS approaches.
Each healthcare provider in Europe (chest physicians and
infectious disease specialists, in particular) should have a copy
of the ISTC on his/her desk, hopefully translated by an
appropriate national professional society or national pro-
gramme in his/her native language. This will help to improve
the quality of care of all TB cases and increase the proportion of
cases successfully treated, while, at the same time, achieve the
national programme targets for TB control. c
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INTERNATIONAL STANDARDS FOR TB CARE
The complete English versions of the International Standards for
Tuberculosis Care and The Patients’ Charter for Tuberculosis
Care (outlining the rights and responsibilities of people with
tuberculosis) are available at www.worldcarecouncil.org.
ACKNOWLEDGEMENTS
The authors wish to thank T. Schaberg and V. Leimane for
their suggestions on the manuscript.
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